From the editors of Review of Ophthalmology and Retina Specialist
THE LATEST PUBLISHED RESEARCH
WELCOME to Review of Ophthalmology's Retina Online newsletter. Each month, Medical Editor Philip Rosenfeld, MD, PhD, and our editors provide you with this timely and easily accessible report to keep you up to date on important information affecting the care of patients with vitreoretinal disease.
SD-OCT Analysis of Risk Factors for Macular Atrophy Development in HARBOR Study
Researchers identified baseline risk factors for macular atrophy development in the HARBOR trial population via a longitudinal assessment of monthly spectral-domain optical coherence tomography scans. Previous analyses of MA in HARBOR examined data from color fundus photography (CFP)/fluorescein angiography.
This was a retrospective, post hoc analysis of SD-OCT images from HARBOR, a Phase III multicenter, prospective, randomized, double-blind, active treatment-controlled clinical trial.
Participants included patients (n=1,097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular treated with intravitreal ranibizumab 0.5 mg monthly (n=275), 0.5 mg as needed after three loading doses (PRN; n=275), 2 mg monthly (n=274) or 2 mg PRN (n=273).
Evaluable SD-OCT macular cube scans from patients with 24 months of follow-up (n=941) were examined monthly from baseline to month 24 by masked reading center-trained graders. Atrophy diagnosis criteria were consistent with those proposed by the Classification of Atrophy Meetings (CAM) group: hypertransmission of light into the choroid, loss of retinal pigment epithelium and loss of outer retinal layers. Multivariable proportional hazards regression was performed for time to atrophy development.
Main outcome measures included risk factors for MA as determined by time to MA development over 24 months of treatment. Here were some of the findings:
• Baseline risk factors for MA were confirmed from prior analyses that used CFP/FA data:
o absence of subretinal fluid;
o presence of intraretinal cysts;
o presence of type 3 neovascularization; and
o presence of atrophy in the fellow eye.
• This analysis of SD-OCT data identified new baseline risk factors for MA:
o higher central drusen volume;
o lower choroidal thickness;
o presence of nascent atrophy;
o presence of reticular pseudodrusen; and
o increased central foveal thickness.
• Ranibizumab treatment regimen and dose level were not found to be risk factors for MA development.
In this analysis of a major nAMD trial using CAM atrophy criteria, researchers identified new baseline risk factors for MA development using an SD-OCT dataset. Researchers also confirmed risk factors for MA development identified by prior analyses. In addition, they wrote that monthly treatment with ranibizumab 0.5 mg was not found to be a risk factor for MA development over 24 months.
SOURCE: Sadda SR, Abdelfattah NS, Lei J, et al. SD-OCT Analysis of risk factors for macular atrophy development in the HARBOR study for neovascular age-related macular degeneration. Ophthalmology 2020; April 3. [Epub ahead of print].
Incidence & Progression of Non-geographic Atrophy in CATT
Investigators wrote that retinal hypopigmentation and hyperpigmentation are precursors of geographic atrophy. They added that incidence and progression to GA in eyes treated with anti-vascular endothelial growth factor for neovascular age-related macular degeneration haven’t been investigated. So, the investigators aimed to determine the incidence and progression of non-GA (NGA)— also known as “incipient atrophy" since it usually precedes GA and is more likely to result in the development of soft drusen and choroidal neovascularization—and associated risk factors.
This study was a post hoc analysis of a cohort study within the Comparison of Age-Related Treatments Trials clinical trial. Participants were recruited Feb. 20, 2008, through Dec. 9, 2009; released from protocol follow-up and treatment after two years; and recalled from March 14, 2014, through March 31, 2015. Data analyses were conducted from Jan. 11, 2019, through Nov. 27, 2019.
Participants were randomized to ranibizumab or bevacizumab for:1) two years of monthly or as-needed injections; or 2) monthly injections for one year and as-needed injections the following year. Participants were treated according to best medical judgment thereafter.
Main outcome measures included incidence of nAMD-associated NGA (hypopigmentation and hyperpigmentation in color images) and progression, with adjusted risk ratios (aRR) for baseline characteristics. Here were some of the findings:
• Among 1,107 participants, risk of NGA was 35 percent (391 eyes) at one year, 59 percent (246 eyes) at two years and 81 percent (122 eyes) at five years.
• Risk factors for NGA included:
o worse visual acuity (20/200 to 20/320: aRR, 1.74 [CI, 1.24 to 2.43] compared with ≤20/40; p=0.006);
o larger neovascularization area (>4 disc areas: aRR, 1.31 [CI, 1.01 to 1.71], compared with ≤1 disc areas; p=0.007);
o switched drug regimen (aRR, 1.28 [CI, 1.06 to 1.54], compared with as-needed injections; p=0.02); and
o single-nucleotide variants Age-Related Maculopathy Susceptibility 2 (ARMS2) (TT variant: relative risk [RR], 1.53 [CI, 1.22 to 1.93]; p=0.001) and HtrA Serine Peptidase 1 (HTRA1) (AG variant: RR, 1.23 [CI, 1.01 to 1.48]; AA variant: RR, 1.51 [CI, 1.20 to 1.91]; p=0.002).
• Sub-retinal pigment epithelium thickness was protective (>275 μm: aRR, 0.59 [CI, 0.46 to 0.75], compared with ≤75 μm; p<0.001).
• Among 389 eyes with NGA by two years and subsequent color images, risk of progression to GA was 29 percent at one year, 43 percent at three years and 50 percent at four years.
• Risk factors for progression to GA included:
o worse visual acuity (20/200 to 20/320: aRR, 2.75 [CI, 1.54 to 4.93], compared with ≤20/40; p<0.001);
o worse fellow-eye visual acuity (<20/40: aRR, 1.77 [CI, 1.12 to 2.79], compared with ≥20/40; p=0.01);
o fellow-eye GA (aRR, 1.71 [CI, 1.06 to 2.75]; p=0.03); and
o pseudodrusen in either eye (aRR, 1.65 [9CI, 1.17 to 2.34]; p=0.005).
• Subretinal fluid was associated with a decreased risk of progression (aRR, 0.42 [CI, 0.28 to 0.63]; p<0.001).
Researchers found that, after two years of protocol-guided anti-VEGF treatment for nAMD, more than half of the eyes in the study developed NGA in the location of nAMD; after three additional years of regular care, half progressed to GA.
Source: Daniel E, Maguire MG, Grunwald JE, et al. Incidence and progression of nongeographic atrophy in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Clinical Trial. Ophthalmology 2020; March 19. [Epub ahead of print.]
Application of Automated Quantification of Fluid Volumes to Anti-VEGF Therapy of nAMD
In a study of wet AMD, researchers say a better way to quantify the disease might help with its treatment. Although researchers wrote that poor outcomes reported from clinical practice are multifactorial, they suggested that the availability of reliable, reproducible and quantitative evaluation tools to accurately measure the fluid response, i.e. a “VEGF meter,” may be a better means of monitoring and treating than the current solely qualitative evaluation used in clinical practice.
This post-hoc analysis of a Phase III, randomized, multicenter study evaluated the eyes of 1,095 treatment-naive subjects receiving pro re nata or monthly ranibizumab therapy, according to protocol-specified criteria in the HARBOR study.
A deep-learning method for localization and quantification of fluid in all retinal compartments was applied for automated segmentation of fluid with every voxel classified by a convolutional neural network (CNN). Three-dimensional volumes (nl) for intraretinal (IRF), subretinal fluid (SRF) and pigment epithelial detachment (PED) were determined in 24,362 volume scans obtained from 1,095 individuals treated over 24 months in a Phase III clinical trial with randomization to two drug dosages (0.5- and 2-mg ranibizumab) and two regimens (monthly and PRN). A multivariable mixed-effects regression model was used to test for differences in fluid between the arms and for fluid/function correlation.
Main outcome measures included fluid volume in nanoliters (nl), structure-function as Pearson’s correlation coefficient and as a coefficient of determination (R2). Fluid volumes were quantified in all visits of all patients. Here were some of the findings:
• Automated segmentation demonstrated characteristic response patterns for each fluid compartment individually: IRF showed the greatest and most rapid resolution, followed by SRF and PED the least.
• The loading dose treatment achieved resolution of all fluid types close to the lowest levels attainable.
• Dosage and regimen parameters correlated directly with resulting fluid volumes.
• Fluid/function correlation showed a volume-dependent negative impact of IRF on vision and a weak positive prognostic effect of SRF.
Researchers reported that automated quantification of the fluid response may improve therapeutic management of neovascular AMD, avoid discrepancies between clinicians/investigators and establish structure/function correlations.
SOURCE: Schmidt-Erfurth U, Vogl W-D, Jampol LM, et al. Application of automated quantification of fluid volumes to anti-VEGF therapy of neovascular age-related macular degeneration. Ophthalmology 2020; March 17. [Epub ahead of print].
Acute Macular & Peripapillary Angiographic Changes with Intravitreal Injections
Scientists wrote that intravitreal injections acutely and temporarily increase intraocular pressure, and this may have cumulative long-term effects including an increased risk for glaucoma surgery. Their study was designed to measure retinal perfusion density changes on optical coherence tomography angiography and OCT thickness alterations associated with acutely increased IOP after intravitreal injections.
The retrospective, observational clinical study of 40 eyes (39 subjects) with various retinopathies from October 2016 to June 2017, at a tertiary care retina clinic in NYC. Patients were older than 18 years, with vision >20/100, able to fixate and without media opacities precluding OCT angiography; and receiving intravitreal bevacizumab or aflibercept for diabetic retinopathy, retinal vein occlusion, macular degeneration, retinal neovascularization or radiation retinopathy. The 3-mm2 macular and 4.5-mm2 peripapillary OCT angiography perfusion density, macular OCT thickness and IOP were measured before and immediately after intravitreal injections. Scientists used the paired T test to compare pre-injection and post-injection values for perfusion density and OCT thickness. They performed regression analysis for potential effects of baseline IOP, IOP change and age. Here were some of the findings:
• Statistically significant decreases in angiographic perfusion density (p<0.05) were found in most areas of the superficial and deep layer macular OCT angiography, and the overall optic nerve head and the radial peripapillary capillary layer, preferentially temporal.
• Macular OCT thickness was significantly decreased in the temporal region and increased in the nasal region.
• Regression analysis showed relationships between age and decreased superficial macular perfusion.
• Pre-injection IOP was only related to OCT thickness in the fovea.
• IOP change was related only to decreased superficial macular perfusion density.
Scientists reported that intravitreal injections produced acute IOP changes that were associated with reduced macular and peripapillary perfusion density. Therefore, they added, it’s possible that patients receiving regular intravitreal injections may be sustaining perfusion-related injury to ocular structures that may produce glaucomatous damage to the macula and optic nerve.
SOURCE: Barash A, Chui TYP, Garcia P, et al. Acute macular and peripapillary angiographic changes with intravitreal injections. Retina. 2020 Apr;40(4):648-656. doi:
Frequency of Rhegmatogenous Retinal Detachment after Intravitreal Therapy in nAMD
Investigators identified characteristics of neovascular age-related macular degeneration patients undergoing pars plana vitrectomy after rhegmatogenous retinal detachment, including changes to injection intervals, as part of a single-center, retrospective, consecutive review.
Subjects included all patients who developed a RRD while receiving anti-VEGF treatment for NVAMD from 1/1/2014 to 10/30/2018. Billing codes were used to identify RRD that occurred within 90 days of a previous intravitreal injection for NVAMD.
Main outcome measures included the quadrant of the retinal break(s), visual acuity at time of RRD and at the final follow-up, and postoperative injection frequency.
An exact total of 203,000 intravitreal injections for neovascular age-related macular degeneration were administered. A total of 17 eyes from 17 individuals demonstrated RRDs, giving a rate of one RRD per 11,941 intravitreal injections (0.0084 percent) within 90 days of intravitreal injection. Here were some of the findings:
• Patients received a mean of 27.56 injections in the superotemporal (ST) quadrant prior to RRD.
• Of known retinal breaks, the ST quadrant was most frequently involved (10 of 16 eyes, 62.5 percent).
• Six patients (35.3 percent) required a second surgery.
• Of patients requiring postop injections, average interval increased from 7.18 weeks preop to 9.17 weeks postop.
• Eleven of 17 (64.7 percent) patients either increased their injection intervals or required no further injections, three maintained similar intervals and three decreased intervals.
• The average number of injections in the six months prior to RRD (total=84) was 4.94 ±1.89; six months after the first post-PPV injection (total=47) it was 2.76 ± 2.44 (p=0.009).
Investigators concluded that the 90-day rate of RRD in NVAMD patients receiving intravitreal injections was low, but that the RRDs in these patients may be more difficult to repair. Moreover, investigators wrote, while many physicians worry about injection frequency in vitrectomized eyes due to a presumed increased medication clearance, this study found that the majority of patients received fewer injections postoperatively.
SOURCE: Mammo DA, Ringeisen AL, Parke III DW, et al. Frequency of rhegmatogenous retinal detachment after intravitreal therapy in neovascular age-related macular degeneration. Ophthalmology Retina 2020; April 14. [Epub ahead of print].
Non-exudative Macular Neovascularization – Systematic Review and OCTA Insights
Researchers wrote that non-exudative macular neovascularization (MNV) is known to be more prevalent in individuals with AMD than initially thought and is bringing new insights into both the natural history and management of the disease.
Researchers conducted a literature search on PubMed, Scopus and Web of Science, along with a manual search, from January 2014 to June 2019. They included studies that used optical coherence tomography angiography as a primary diagnostic tool to evaluate subclinical (treatment-naïve), non-exudative, neovascular AMD.
Of the 258 screened articles, 12 were included. Here were some of the findings:
• The prevalence of subclinical non-exudative neovascular AMD in the fellow eyes of individuals with unilateral exudative AMD ranged from 6.25 to 27 percent. Although the lesions weren’t associated with a significant decrease in visual acuity, researchers wrote that the presence of non-exudative MNV seemed to be an important predictor of exudative disease.
• Incidence of exudation in the reviewed studies ranged from 20 to 80 percent (follow-up: six months to two years).
• There was some evidence that non-exudative MNV might have slowed down the growth of adjacent geographic atrophy.
• As long as exudation didn’t occur, it appeared that subclinical non-exudative MNV wasn’t responsible for the deterioration of visual function.
Researchers wrote that non-exudative MNV is an asymptomatic condition. While it appeared to be a precursor for the formation of exudative neovascular AMD, some evidence suggested a protective effect in slowing the progression of GA. Researchers added that early detection of non-exudative MNV before exudation develops should result in better monitoring of individuals at high risk of conversion to exudative AMD. While no controlled clinical trial has been performed to provide definitive recommendations, the authors of the studies agreed that non-exudative lesions shouldn’t be treated until symptomatic exudation develops. Moreover, the researchers wrote, the existence of a non-exudative form of neovascular AMD suggested that the term “neovascular AMD” should be preceded by “exudative” or “non-exudative” when describing the neovascular stage of AMD.
SOURCE: Laiginhas R, Yang J, Rosenfeld PJ, et al. Non-exudative macular neovascularization – a systematic review of prevalence, natural history, and recent insights from OCT angiography. Ophthalmology 2020; March 13. [Epub ahead of print].
Safety & Efficacy of Brimonidine Drug Delivery System in GA Secondary to AMD
Researchers evaluated the safety and efficacy of the Brimonidine Drug Delivery System (Brimo DDS), a biodegradable intravitreal implant, in the treatment of geographic atrophy secondary to age-related macular degeneration, as part of a Phase II, randomized, multicenter, double-masked, 24-month study sponsored by the implant's maker Allergan.
Study eyes were treated on day one, and then with a retreatment at month six, with Brimo DDS 132 µg (n=49), Brimo DDS 264 µg (n=41) or sham procedure (n=23). The primary timepoint for efficacy analysis was month 12. Here were some of the findings:
• Mean GA area growth at month 12 was 1.78 mm2 in the Brimo DDS 132 µg, 1.59 mm2 in the Brimo DDS 264 µg group, and 2.19 mm2 in the sham group.
• Geographic atrophy area growth was consistently smaller with Brimo DDS 132 and 264 µg than the sham group; between-group differences were significant (p≤0.032) at month three.
• In patients with baseline lesion area ≥6 mm2 (two-thirds of patients), GA lesion area and effective radius growth was reduced with Brimo DDS 132 and 264 µg at month 12 (p≤0.050 vs. sham).
• Treatment-related adverse events were usually injection procedure-related.
Researchers found that Brimo DDS demonstrated a favorable safety profile and reduced GA lesion area growth at month three. They reported that lesion growth at month 12 was reduced in individuals with baseline GA lesion area ≥6 mm2. They say the results support Phase III development.
SOURCE: Kuppermann BD, Patel SS, Boyer DS, et al. Phase 2 study of the safety and efficacy of brimonidine drug delivery system (Brimo DDS) generation 1 in patients with geographic atrophy secondary to age-related macular degeneration. Retina 2020; Mar 3. [Epub ahead of print].
Progression of Unifocal vs. Multifocal GA in AMD: A Systematic Review and Meta-analysis
Researchers aimed to determine the natural history of unifocal vs. multifocal geographic atrophy secondary to non-exudative age-related macular degeneration. They wrote that the association between GA focality (i.e., unifocal vs. multifocal lesions) and enlargement rate is inconsistent in the literature, with some studies reporting a comparable growth rate between unifocal and multifocal GA, while others suggesting the growth rate varies widely between the two groups.
Researchers searched five literature databases up to May 3, 2019, for studies that classified treatment-naïve GA patients based on lesion focality. They performed random effects meta-analyses to determine the growth rates of GA. To account for different entry times among cohorts, they introduced a horizontal translation factor to the dataset of each cohort. Heterogeneity was assessed using I2 statistic and study quality was evaluated using the Quality in Prognosis Studies tool. Publication bias was evaluated by funnel plots and the Egger test.
Researchers included 12 studies with 3,489 eyes from 3,001 patients. Here were some of the findings:
• After the introduction of translation factors, the effective radius of unifocal and multifocal GA enlarged linearly over approximately seven years.
• The effective radius growth rate of multifocal GA (0.199 ±0.012 mm/year) was 46.3 percent higher than the growth rate of unifocal GA (0.136 ±0.008 mm/years) (p<0.001).
• Unifocal and multifocal GA lesions with the same total baseline area grew at vastly different rates, with an estimated ratio of the growth rate as 1.46 (between √2 and √3). This difference disappeared after researchers accounted for different baseline total perimeter between unifocal and multifocal groups.
• The measured GA growth rate was consistent across studies using color fundus photography, fundus autofluorescence or optical coherence tomography (p=0.35 to 0.99).
Researchers concluded that the effective radius of GA enlarged linearly and steadily over time in unifocal and multifocal GA. They added that lesion focality is a significant prognostic factor for the GA effective radius growth rate. Researchers proposed that the growth rate of the GA area was directly proportional to the total lesion perimeter—a measure of the number of retinal pigment epithelium cells exposed at the lesion border. They advised that additional studies would be needed to understand the cellular mechanisms underlying this relationship.
SOURCE: Shen LL, Sun M, Grossetta Nardini HK, et al. Progression of unifocal vs. multifocal geographic atrophy in age-related macular degeneration: A systematic review and meta-analysis. Ophthalmology Retina 2020; April 4. [Epub ahead of print].
Five-Year Outcomes After Initial Aflibercept, Bevacizumab or Ranibizumab Treatment for DME
Researchers assessed follow-up treatment and clinical outcomes at five years in eyes initially treated with anti-VEGF therapy for center involved diabetic macular edema (CI-DME) in a two-year randomized clinical trial, as part of a multicenter cohort study.
Participants included individuals with DME and visual acuity of 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits five years after randomization (three years after Protocol T completion). Individuals were assigned randomly to aflibercept, bevacizumab or ranibizumab with protocol-defined follow-up and retreatment for two years. Thereafter, participants were managed at clinician discretion and recalled for a five-year visit.
Main outcome measures included anti-VEGF treatment, VA letter score and central subfield thickness. Sixty-eight percent (317 of 463) of eligible participants completed the five-year visit. Here were some of the findings:
• Between years two and five, 68 percent (217 of 317) of study eyes received at least one anti-VEGF treatment (median [interquartile range] 4 [0, 12]).
• At five years, mean VA improved from baseline by 7.4 letters (CI, 5.9 to 9), but decreased by 4.7 letters (CI, 3.3 to 6.0) between two and five years.
• When baseline VA was 20/50 to 20/320, mean five-year VA was 11.9 letters (CI, 9.3 to 14.5) better than baseline, but 4.8 letters (CI, 2.5 to 7) worse than at two years.
• When baseline VA was 20/32 to 20/40, mean five-year VA was 3.2 letters (CI, 1.4 to 5) better than baseline, but 4.6 letters (CI, 3.1 to 6.1) worse than at two years.
• Mean central subfield thickness decreased from baseline to five years by 154 μm (CI, 142 to 166), and was stable between two and five years (-1 μm [CI, -12 to 9]).
Researchers reported that, among the two-thirds of eligible Protocol T participants who completed a five-year visit, mean VA improved from baseline to five years without protocol-defined treatment after follow-up ended at two years. Although mean retinal thickness was similar at two and five years, mean VA worsened during this period. Researchers wrote that additional investigation into strategies to improve long-term outcomes in eyes with DME was warranted to determine if VA could be better maintained with different management approaches.
SOURCE: Glassman AR, Wells III JA, Josic K, et al. Five-year outcomes after initial aflibercept, bevacizumab, or ranibizumab treatment for diabetic macular edema (protocol t extension study). Ophthalmology 2020; March 28. [Epub ahead of print].
Combined Phacoemulsification & Vitrectomy for Retinal Detachment
Scientists evaluated and compared the anatomical and functional results of phacovitrectomy and pars plana vitrectomy alone for phakic rhegmatogenous retinal detachment.
The retrospective, comparative case series looked at 266 phakic eyes that underwent either combined phacovitrectomy or PPV alone for primary retinal detachment. The primary anatomical success rate, final best-corrected visual acuity and refractive outcomes were analyzed.
A total of 127 eyes were included in the combined group and 139 in the PPV group. Here were some of the findings:
• The primary anatomical success rate was 84.3 percent in the combined group and 89.2 percent in the PPV group (p=0.311).
• One hundred and nine eyes (78.4 percent) of the PPV group required cataract removal for visual rehabilitation during the follow-up period.
• No significant difference was found between the two groups in terms of the mean final best-corrected visual acuity (p=0.185) and mean visual changes (p=0.470).
• Overall, combined cataract extraction resulted in a significant myopic shift compared with delayed cataract surgery (p=0.047).
Scientists wrote that combined phacoemulsification and PPV was a safe and effective procedure to treat retinal detachment. They added that the anatomical and functional results were comparable with those obtained with PPV and delayed cataract surgery. However, they continued, refractive outcomes were less favorable and shifted toward myopia, especially in macula-off cases.
SOURCE: Tan A, Bertrand-Boiché M, Angioi-Duprez K, et al. Outcomes of combined phacoemulsification and pars plana vitrectomy for rhegmatogenous retinal detachment: A comparative study. Cornea 2020; April 3. [Epub ahead of print].
CMS Expands Accelerated & Advance Payment Program
The Centers for Medicare & Medicaid Services announced an expansion of its accelerated and advance payment program for Medicare participating health-care providers and suppliers to ensure they have the resources needed to combat COVID-19. This program expansion, which includes changes from the recently enacted Coronavirus Aid, Relief, and Economic Security (CARES) Act, is intended to lessen the financial hardships of providers facing challenges related to the COVID-19 pandemic. Read more.
Source: CMS, March 2020
NEW BREATH SHIELD PROTECTS EYE DOCTORS AND PATIENTS
Doctors and engineers at the University of Michigan developed an expanded breath shield that they say can provide greater protection to doctors and patients during eye exams amid COVID-19. U-M engineers moved quickly to design an acrylic plexiglass panel that would fit and work with slit lamps, and the panels have been installed at the Kellogg Eye Center. Slit lamps currently on the market feature breath shields that are a maximum of eight inches on any side. At the request of doctors at Kellogg, a U-M team led by Lauro Ojeda, an associate research scientist in mechanical engineering, designed and prototyped a larger shield that is 12 inches by 15 inches. Ojeda and his team are making the design specs for their shields available to the public and are designing shields for portable slit lamps. Read more.
SOURCE: The Michigan Engineer News Center, April 2020
COMPANIES EXTEND PAYMENT TERMS FOR ANTI-VEGF INJECTIONS
In response to the COVID-19 pandemic, both Regeneron and Genentech are making it easier to pay for your doses of Eylea and Lucentis, respectively.
Regeneron says it temporarily extended physician payment terms for Eylea (aflibercept) injection purchases from authorized distributors to 150 days, 50 days more than the previous 100-day terms. This has no impact on current Eylea return policies, the company says. Regeneron says that physicians may be temporarily eligible for payment terms of up to 150 days, subject to distributor qualification. Ophthalmologists are urged to verify the timing and specific dating terms that apply to their offices with their authorized distributors of record.
Regeneron aimed to have implemented these new temporary terms by April 1, 2020 and intends to have these new terms apply retroactively for Eylea (vial or prefilled syringe) purchased on or after March 1, 2020. Read more.
Genentech temporarily extended physician payment terms for Lucentis purchases from authorized distributors to 120 days. They implemented these new, temporary payment terms for purchases from April 1, 2020, as well as retroactively for Lucentis purchased on or after March 1, 2020. Practices may be temporarily eligible for payment terms of up to 120 days (previously 60 days), subject to distributor qualification. The company is asking practitioners to contact their specialty distributor with questions or to verify the new terms.
SOURCES: American Academy of Ophthalmology and Genentech, March 2020
ASRS PROVIDES GUIDANCE ON MANAGING COVID-19 RISK IN RETINAL PROCEDURES
Guidance from the American Society of Retina Specialists says retina specialists need to weigh the risk for vision loss against the risk for COVID-19 when deciding which patients should be seen urgently vs. those whose treatment can be delayed. The recommendations address aspects unique to the subspecialty as well as factors of concern in the clinic and in the operating room. The guidance emphasizes that only patients who require essential treatment should be seen. These include new emergency patients, those receiving intravitreal injection therapy, and early postoperative follow-up patients. Read more.
SOURCE: American Society of Retina Specialists, March 2020
IVERIC ANNOUNCES FAST TRACK DESIGNATION FROM FDA FOR ZIMURA
The FDA granted Fast Track designation to Zimura (avacincaptad pegol), a novel complement C5 inhibitor in development for the treatment of geographic atrophy secondary to dry age-related macular degeneration, Iveric announced. The FDA created the Fast Track process to facilitate development and expedite the review of drugs to treat serious or life-threatening diseases or conditions, which have the potential to fill an unmet medical need. Currently, no FDA-approved treatment option is available for patients with GA secondary to dry AMD. Read more.
SOURCE: Zimura, April 2020
OD-OS Introduces App Guide Retinal Laser Treatment
OD-OS, the company offering the Navilas 577s Navigated Retina Laser surgery system, introduced a free app designed to support retina residents onsite and online. The company says the app offers an interactive way of supporting medical decision-making for retinal laser treatments based on cases from clinical practice. Learn more.
SOURCE: OD-OS, April 2020
SECOND SIGHT EXPLORES BUSINESS OPTIONS
Second Sight Medical Products, maker of the Argus II and Orion retinal implants, announced that it has taken significant steps to reduce overhead and conserve liquidity as it continues operations while assessing strategic options. These options include securing additional funding and exploring business alternatives that may include partnering, acquiring, investing in or combining with businesses that may or may not be in a related industry. The company remains encouraged by the positive interim results from the six subjects at the Ronald Reagan UCLA in Los Angeles and the Baylor College of Medicine in Houston who have been implanted with the Orion Visual Cortical Prosthesis System, and the potential to advance the technology into larger clinical studies to treat profound blindness arising from nearly all forms of preventable blindness. In March, the company had announced it would lay off approximately 84 of its 108 employees effective March 31 and would pursue an “orderly wind down” of the company’s operations, as a result of the global COVID-19 pandemic and the company’s inability to secure financing. Read more.
Source: Second Sight Medical Products, April 2020
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